To provide information on the response of HIV infected, neurosyphilis patients to the
currently recommended treatment for neurosyphilis; to determine whether possible
co-infection with both HIV and syphilis makes more difficult the diagnosis of syphilis; to
explore the usefulness of an alternative treatment which, if effective, would permit
outpatient treatment for neurosyphilis that until now required prolonged hospitalization.
Studies suggest that syphilis treatment failures may be more common in HIV infected patients
than in patients without HIV infection and that treatment failures occur due to and/or are
displayed as central nervous system (CNS) involvement. Very little is known about the best
treatment course for neurosyphilis in patients who are also infected with HIV.

To provide information on the response of HIV infected, neurosyphilis patients to the
currently recommended treatment for neurosyphilis; to determine whether possible
co-infection with both HIV and syphilis makes more difficult the diagnosis of syphilis; to
explore the usefulness of an alternative treatment which, if effective, would permit
outpatient treatment for neurosyphilis that until now required prolonged hospitalization.
Studies suggest that syphilis treatment failures may be more common in HIV infected patients
than in patients without HIV infection and that treatment failures occur due to and/or are
displayed as central nervous system (CNS) involvement. Very little is known about the best
treatment course for neurosyphilis in patients who are also infected with HIV.

A subgroup of patients with childhood-onset obsessive-compulsive disorder (OCD) and/or tic
disorders has been identified who share a common clinical course characterized by dramatic
onset and symptom exacerbations following group A beta-hemolytic streptococcal (GABHS)
infections. This subgroup is designated by the acronym PANDAS (Pediatric Autoimmune
Neuropsychiatric Disorders Associated with Streptococcal infections). There are five
clinical characteristics that define the PANDAS subgroup: presence of OCD and/or tic
disorder; prepubertal symptom onset; sudden onset or abrupt exacerbations
(relapsing-remitting course); association with neurological abnormalities (presence of
adventitious movements or motoric hyperactivity during exacerbations); and temporal
association between symptom exacerbations and GABHS infections. In this subgroup, periodic
exacerbations appear to be triggered by GABHS infections in a manner similar to that of
Sydenham's chorea, the neurological variant of rheumatic fever.
Rheumatic fever is a disorder with a presumed post-streptococcal autoimmune etiology. The
streptococcal pathogenesis of rheumatic fever is supported by studies that have demonstrated
the effectiveness of penicillin prophylaxis in preventing recurrences of this illness. A
trial of penicillin prophylaxis in the PANDAS subgroup demonstrated that penicillin was not
superior to placebo as prophylaxis against GABHS infections in these children, but this
outcome was felt to be secondary to non-compliance with treatment, and there was no decrease
in the number of neuropsychiatric symptom exacerbations in this group. In a study comparing
azithromycin and penicillin, both drugs were completely effective in preventing
streptococcal infections - there were no documented titer elevations during the year-long
study period for children taking either penicillin or azithromycin. Comparable reductions in
the severity of tics and obsessive-compulsive symptoms were also observed. Thus, penicillin
was not performing as an "active placebo" as originally postulated, but rather provided
effective prophylaxis against Group A beta-hemolytic streptococcal. Both azithromycin and
penicillin appear to be effective in eliminating GABHS infections, and reducing
neuropsychiatric symptom severity; thus, between-group differences are negligible. Since
increasing the "n" to demonstrate superiority of one prophylactic agent over another would
be impractical, we have amended the study design to address two issues:
1. To determine if antibiotics prophylaxis against GABHS infections is superior to placebo
in prolonging periods of remission among children in the PANDAS subgroup.
2. To determine if antibiotics prophylaxis against GABHS infections is superior to placebo
in improving overall symptom severity for obsessive-compulsive symptoms and tics among
children in the PANDAS subgroup.
Because penicillin has a narrower therapeutic index and is less expensive than azithromycin,
it is the preferable prophylactic agent. Further, penicillin (250 mg orally twice a day) has
a long history of providing safe and effective prophylaxis for rheumatic fever and is the
first line oral therapy recommended by the American Heart Association. Thus, penicillin has
been chosen as the prophylactic antibiotic in the present study. Blister packs are used to
increase compliance and to allow for easier documentation of missed doses.

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